“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”
Passing the Test: New York's Newborn
HIV Testing Policy, 1987-1997
This appendix traces the evolution of
policy in New York State regarding the screening of newborns for HIV
antibodies, from the introduction of the blinded newborn seroprevalence
survey in November 1987 through the implementation of the mandatory newborn
testing and notification begun in February 1997. It is intended to provide
the reader with the context in which key policies were debated or enacted
and a sense of who the key players were. A caveat for the reader: since this
material spans over a decade's worth of activity and discourse around a
highly charged emotional issue, as a chronological accounting it can only
touch upon key events and personalities. Moreover, an effort has been made
to present the issues and decisions objectively by outlining the arguments
advanced for certain decisions or policies, rather than arguing the merits
of one point of view over another.
Data for this appendix were collected
through confidential key informant interviews, literature reviews, and
archival material review (such as program documentation and newspaper
reports). Because many of the informants are currently involved in policy
making and public health activities and might otherwise feel constrained
from being completely candid if their comments would be publicly attributed,
individuals' insights and comments have been intertwined within the
narrative without identifiable attribution.
This particular case of newborn screening
policy in New York offers insights into the state's broader politics and
policy making surrounding HIV/AIDS. Several of the key lessons include the
- Policies and
advocacy efforts from the 1960s through the 1990s produced a confluence of
the patients' right movement, community engagement models, and categorical
funding streams that resulted in a public health environment far more
sensitive to individual privacy rights, patient autonomy, special
interests and particularized communities than the more traditional mandate
of public health operating solely for a majoritarian "public good."
- Advocates for
people affected by HIV/AIDS have consistently challenged the traditional
public health roles of surveillance, resource distribution, and case
finding--and particularly the consequences of these traditional policies
and programs for disenfranchised populations--and in so doing have
compelled "exceptionalist" policies regarding HIV/AIDS that differ in many
important aspects from other communicable or sexually transmitted diseases
(STDs). New York's newborn screening debate embodied the struggle between
the traditional and the exceptionalist approaches.
- As the issue of
newborn surveillance evolved from an insular public health issue to one of
political moment, who framed the issue and how the issue was framed became
the two most important predictors of public opinion.
- The locus of
decision making shifted over the course of a decade, as did the arena in
which debate was engaged. Once public health policy was being debated in a
political arena (and particularly once it reached a certain crescendo),
the ultimate decisions and considerations were more often related to their
political consequences than to their health consequences. When the testing
policy changed in 1996 and 1997 (first with "consented" testing and then
with mandatory testing), this occurred primarily because of shifting
political winds and not because of scientific sea changes.
- As originally
conceived, the state's newborn screening program addressed "public health
uncertainty" about the epidemiology of HIV, but could not resolve the
"medical uncertainty" of a clinician unaware of a patient's status, and
therefore reinforced the divide between the population orientation of the
state and the patient orientation of the clinician.
- Although New York's
initial newborn testing policy revolved around surveillance and its
epidemiological utility for charting the epidemic and for program
planning, the legislative battle focused on newborn testing for the
purposes of case finding. When the political debate was first
engaged in 1993, there was scant evidence that mandatory testing would
result in any decrease in perinatal transmission. Although there
was a consensus regarding secondary prevention of Pneumocystis carinii
pneumonia (PCP) among infants using pentamidine prophylactically, and the
Centers for Disease Control and Prevention (CDC) had issued guidelines
regarding HIV-positive mothers abstaining from breast-feeding (which might
be delayed up to six weeks awaiting test results and follow-up), the
medical and public health communities were divided on the absolute benefit
of newborn testing as a means of reducing perinatal transmission. Even as
the scientific landscape changed (particularly concerning the clear
evidence for intervening in the prenatal period) the terms of the newborn
testing debate remained fixed. Given the advent of rapid testing and the
potential value of zidovudine (ZDV) therapy antenatally, medical science
is only now beginning to demonstrate any evidence for proactively
identifying HIV-antibody-carrying infants at birth. The cornerstones of
the political discourse on the testing policy, though, were predicated on
emotional and political issues, not scientific ones. Furthermore, as a
case finding tool, newborn testing was principally effective only in
identifying the mother. When the issue was first raised legislatively in
1993, there was no system of follow-up care or any reliable way to assure
that all HIV-positive babies were accurately identified when they
- Given the players,
the program, and the shifting political environment, it is likely that
mandatory testing was inevitable in New York State. The mandatory newborn
testing policy has also facilitated the successful passage of other HIV
legislation in New York, such as mandatory partner notification and named
The chronology of newborn testing policy
unfolded in a shifting context of decision making and debate: from insular
public health (the pragmatic era), to the population/clinical split (the era
of mounting clinical frustration), to the political arena (marked by
polarization, issue framing, and political "processes" of negotiation and
pressure), to clinical optimism (retroviral therapy and protease
inhibitors), and a return to public health pragmatism (the implementation of
a political decision).
There were two points of strong federal
state interaction regarding newborn screening, and the nature of each
reveals a great deal about the shifting eras. In 1987, the CDC strongly
supported New York's surveillance efforts as a complement to its "Family of
Surveys" and provided half the ongoing funding for New York's newborn
screening program. This was clearly the era of public health pragmatism,
particularly in the face of uncertainty about the epidemic's future path. In
19951996, there was increasing political momentum at the federal level
(evidenced by amendments to the Ryan White Reauthorization Act proposed by
Congressmen Tom Coburn and Gary Ackerman) for mandatory newborn testing.
With the sweep of Republicans into U.S. Congress, and similar Republican
inroads in the New York State legislature (and the change at the executive
level from a Democratic to a Republican governor), the Democratic-controlled
Assembly faced increasing political pressure to conform to the governor's
wishes for a mandatory newborn testing program. In 1996, after quiet
negotiations between several key legislative players, the New York State
Assembly speaker reversed his three-year opposition to mandatory testing and
helped pass the "Baby AIDS" bill.
The framing and marketing of the issue of
newborn screening and testing played a significant part in the decisions and
actions taken. The early blinded screening program publicized its findings
of high seroprevalence rates among women in inner-city communities, and the
news was presented as that of epidemiologic discovery. The emerging pattern
of HIV transmission--with its growing impact on communities of heterosexual
women and their offspring, in some neighborhoods as high as 4%--served as
the impetus for a number of prevention and education efforts. In contrast,
once the issue entered the political arena, the debate was waged in the
realm of public opinion. Those who favored mandatory newborn testing
presented the issue as one of villains and victims. The villain in this case
was "Big Brother" government, armed with specific knowledge about a baby
that could save his/her life, thwarting the victims--dedicated doctors and
caring mothers--from saving HIV-infected babies. The counterarguments were
far subtler, often relying upon biostatistical arguments, legal or ethical
frameworks, or advocacy on behalf of minority women. Although those opposed
to mandatory testing advocated a model of voluntary HIV testing, which
presumably worked to foster trust between a health care provider and a
mother and capitalized on maternal instincts to protect a baby's welfare,
the images could not compete with those of HIV-infected babies being denied
treatment by an uncaring government.
Finally, what state public health officials
had recognized early on--that using the sentinel event of birth as a primary
epidemiological marker because it was universal, occurred in an
institutional setting over which the state had considerable regulatory
power, and was built upon a successful newborn genetic screening
program--carried equal appeal for policy makers. Whether the state was
interested in HIV surveillance or case finding, the birth of a baby appeared
to provide a perfect opportunity.
THE PUBLIC HEALTH ENVIRONMENT, 19801986
New York's city and state health
departments confronted a number of sensitive issues in the first few years
of the AIDS epidemic: the regulation of sexual behavior in commercial
bathhouses, clean needle exchanges for injection drug users, and the
development of voluntary HIV testing programs, among others. Each issue
posed its own policy challenge. In considering bathhouse closures, public
health officials weighed the benefit of using their police powers against
the consequence of threatening a particular group's civil liberties. With
proposed needle exchange programs, they tried to balance the moralism of
antidrug policies and politics with the pragmatism of stemming an avenue of
transmission. As HIV tests became available in 1985, officials had the task
of inspiring trust among groups that were wary of a government's ability to
preserve an individual's privacy and confidentiality. From the debates that
arose among public health officials, interest groups and affected
individuals, health care providers, and political leaders, a general
strategy of voluntary risk reduction and HIV prevention programs emerged.
Rather than use their prerogative to close gay bathhouses, bars, and other
public venues, public health officials first sought voluntary compliance
from the gay community. Only after the voluntary effort had failed did the
state compel the closure of commercial bathhouses. The health commissioners
had less success with needle exchange programs. Although sequential New York
City Health Commissioners David Sencer and Stephen Joseph both endorsed
needle exchange programs, and New York State Health Commissioner David
Axelrod was also willing--albeit reluctantly--to experiment with such
approaches, the proposed programs generated too much political opposition.
It was not until 1989 that a limited needle exchange demonstration was
approved for New York City. The lessons reinforced by these two issues were
clear: individual rights matter and politics matter. To craft strategic
programs, public health officials had to appease civil libertarians and
advocacy groups at one end of the political spectrum and political
conservatives at the other end.
The HIV antibody test developed in 1985 as
a means of safeguarding the blood supply raised the greatest specter of
government intrusion into an individual's private domain. Although public
health officials did not universally endorse a voluntary HIV testing program
initially (it was, in fact, opposed initially by the city health
commissioner), by the end of 1985 most health officials acknowledged the
test's utility for preventing transmission of the virus. The HIV test,
however, was regarded by its opponents as the linchpin for a number of
potentially intrusive measures--registries of HIV-infected individuals
(which could both stigmatize and lead to discrimination if the names were
ever revealed), mandatory partner notification programs, impingement of
women's reproductive choices, and potential deportation of infected
immigrants. In response to these concerns, public health officials and
policy makers reinforced the exceptionalist nature of AIDS policy--rather
than using the traditional reporting requirements and contact tracing
associated with sexually transmitted and other communicable diseases, New
York health officials carved out explicit informed consent requirements and
voluntary HIV testing and notification policies. Behind such policies was an
implicit quid pro quo. In return for relying upon various risk groups'
voluntary compliance with these prevention strategies, public health
officials would withhold a compulsory approach. Given the absence of any
reliable treatment in the mid-1980s, public health officials' reliance upon
voluntary prevention efforts seemed the most prudent course of action.
New York's innovative administration of its
AIDS programs further reflected its awareness that this disease required a
different approach than others. The AIDS Institute was established as an
independent center within the state health department in 1982, at first
reporting to the director of the Center for Community Health (an umbrella
unit for all community-based public health activities) and later reporting
directly to the commissioner of health. The broad mandate of the AIDS
Institute included strategic planning, the oversight of community and
clinical programs, the synthesis of epidemiological and evaluation data for
planning purposes, and policy development. The Bureau of HIV/AIDS
Surveillance operated separately from the AIDS Institute and worked as a
component of the state's epidemiology unit. The surveillance group was
responsible for analyzing data provided by the state's Wadsworth Laboratory,
which represented the third leg of the administrative tripod. Finally, the
state legislature created the AIDS Advisory Council (staffed by the AIDS
Institute) as a forum to provide the health commissioner with input from
both health care providers and communities affected by AIDS. The AIDS
Advisory Council served as a buffer between vocal community advocacy groups,
program planners within the health department, and the state legislature.
Among the council's roles were developing proposed statewide AIDS budgets,
identifying special needs populations, and lobbying politicians on
designated "Legislators Days." According to one knowledgeable observer, "The
AIDS budget is unique. It is laid out in lines that are more specific than
the overall department's budget, because of visibility and political action.
Each group of constituencies is represented in a separate line, such as a
budget line for 'High risk women and children.' " Prior to the current
administration, which began in 1995, the AIDS Institute also had its own
policy office, distinct from the health department's, which oversaw an
interagency policy committee that coordinated the AIDS policy work of a
number of state agencies and units. AIDS policy in New York was clearly
exceptional and political, and the locus of decision making was in the hands
of Dr. David Axelrod, the state's health commissioner.
PUBLIC HEALTH PRAGMATISM, 19871990
At the Third International AIDS Conference
in Washington, D.C. in the summer of 1987, the State of Massachusetts
reported on its anonymous newborn screening program for HIV antibodies,
which had been operational for a year. The first state in the nation to
conduct such surveillance, Massachusetts had capitalized on its newborn
screening program for genetic and metabolic disorders in order to test for
the presence or absence of maternal HIV antibodies in a baby's blood. Two
high-ranking New York public health officials, Lloyd Novick, the director of
the Center for Community Health (which oversaw both the epidemiology unit
and the AIDS Institute at the time), and Donald Berns, the assistant
director of the state-run Wadsworth Center for Laboratories and Research,
were very impressed by Massachusetts's presentation. Berns assured Novick
that they had the laboratory capacity to conduct such a surveillance effort
in New York. They returned to New York intent on developing an even more
sophisticated screening program. The two met with Health Commissioner David
Axelrod and Herbert Dickerman, the head of the Wadsworth Labs, and began
planning the newborn surveillance program. From the onset, the four
determined to improve on the Massachusetts surveillance program by also
collecting demographic data, including the zip code of the mother (or the
hospital if the mother's zip code was unavailable), maternal age, and the
race/ethnicity of the infant.
Although the planners' principal concerns
at first were those of logistics and capacity--securing a sufficient blood
sample from a newborn heel-stick; designing the data form for accurate
coding; removing identifiers; developing the epidemiological framework to
use the data collected by the labs, conduct small- and large-area analyses,
and report findings--the health department officials acknowledged in their
meetings that the issue of dealing with HIV-positive results was of some
concern. The universal newborn screening program had to be built on research
conducted on anonymous blood samples. If mothers were approached for consent
to test their newborn's blood it would raise issues of potential bias, since
not all mothers would consent and the resultant sample might not be
representative of the population of childbearing women. Since the
surveillance therefore had to be conducted in anonymous fashion, "blinded"
to those drawing the blood and those analyzing the blood, the health
department had no legal authority or capacity to then identify those babies
testing HIV-positive and notify the mother. In addition to the planned
newborn serosurvey, New York public health officials were also designing
serosurveys that provided epidemological data among population "windows" for
whom blood was routinely collected--drug users, state prisoners, runaways
and homeless teens referred to medical examinations, and family planning and
STD clients, in addition to newborns.
The decision to launch the blinded newborn
seroprevalence survey and related serosurveys rested with these four public
health officials, and principally with Health Commissioner Axelrod. As one
of Governor Cuomo's most trusted cabinet members, Axelrod was afforded a
great deal of latitude in formulating public health policy and was well
respected by members of the state legislature. Axelrod's management style
was such that he relied upon a close circle of high-ranking deputies for
their counsel, and all major decisions funneled up to him. To assure himself
that his strategies were sound both scientifically and ethically, Axelrod
often convened committees of outside experts to consider the effectiveness,
consequence, or significance of particular policies or programs. In
mid-September 1987, Axelrod brought together clinicians and ethicists to
review the gamut of proposed seroprevalence surveys--the "windows" into
various populations--and particularly the newborn screening study. The
Advisory Committee (composed of Elaine Abrams of Harlem Hospital, Daniel
Callahan of the Hastings Center, Victor DeGruttola of Harvard School of
Public Health, Richard Kaslow from the National Institute for Allergy and
Infectious Diseases, the CDC's Magarite Pappaioanou, and Warren Winkelstein
from the University of California at Berkeley) unanimously supported the
universal newborn screening program.
The blinded newborn seroprevalence study
built upon the state's established Newborn Screening Program (NSP), which
tested infants at hospital discharge for seven inherited disorders (phenylketonuria
[PKU], congenital hyperthyroidism, and maple sugar urine disease, among
others) by drawing blood through a heel-stick. The NSP had been developed in
New York State in the early 1960s by a Buffalo microbiologist Dr. Robert
Guthrie. He had watched in horror as his niece had gone undiagnosed with PKU
until she was 16 months old; she grew up retarded and schizophrenic, which
he attributed to the initially undiagnosed PKU. His impetus to develop the
newborn screening was that if PKU was detected early enough after birth,
babies could be put on a special low-protein diet and go on to lead
perfectly normal lives. On average, New York screens over 300,000 infants
each year and identifies approximately 12 children with PKU. (In contrast,
in a nine-month period from February 1, 1997, through October 31, 1997, of
185,540 births there were 779 infants born with maternal HIV antibodies.)
The state health department began
collecting newborn HIV seroprevalence data on November 30, 1987. "What I
recall quite vividly," said one of the study planners, "is that after the
first two weeks we were taken aback by the results. They had quite an impact
on us." Several earlier newborn studies conducted in municipal hospitals in
New York City had revealed seroprevalence rates of 2.4% to 2.5%. The study
planners expected to find similar data in high-risk neighborhoods and were
stunned to find rates of 4% seroprevalence in Harlem, the South Bronx, and
the Bedford Stuyvesant section of Brooklyn. "This meant that 1 of every 25
women [delivering a baby] was infected," noted a public health official,
"and when we reported that we expected a big outcry, and a large media push,
for us to immediately unblind the survey." To their surprise, newspaper
coverage focused on the epidemiological significance of the findingson the
spread of HIV infection across the state and the depth of HIV seroprevalence
in particular communities.
Within four weeks of starting the newborn
seroprevalence study, the state health department had amended the contracts
of state-regulated family planning programs and prenatal care clinics, which
served over 300,000 women annually, requiring them to provide on-site HIV
counseling and testing services. The state also stepped up its efforts to
reach pregnant women in high-risk neighborhoods through its Community Health
Worker program and through targeted education campaigns, and advised
obstetricians and other physicians throughout the state of the compelling
need to provide HIV counseling and testing services to women of reproductive
age. In his State of the State message on January 6, 1988, Governor Mario
Cuomo told the assembled legislators, "There is no greater tragedy than the
birth of a child condemned to death, yet estimates indicate 1,000 infants
will be born with the AIDS virus in 1988. . . . The initial results of the
prevalence studies have only served to heighten our sense of urgency and to
focus dramatically upon our most vulnerable populations. Results on the
first 11,000 newborn blood specimens demonstrate an alarming statewide HIV
seroprevalence rate of almost 1% among women of childbearing age."
At the same time that New York was
beginning its seroprevalence studies, the CDC was initiating its Family of
Surveys seroprevalence sample studies in 45 states. The CDC funded states to
conduct anonymous seroprevalence studies on representative samples of
injection drug users, STD and tuberculosis clinic patients, hospital
admissions, patients at clinics serving women of reproductive age, and
newborns. New York public health officials decided to conduct universal,
anonymous screening rather than sampled screening, since it was piggybacking
the study on the universal Newborn Screening Program and the additional cost
was warranted by the greater predictive power of conducting a universal
test. The CDC contributed funding that covered half of New York's
seroprevalence studies, and the state made up the difference (by 1996, the
state was paying three-quarters of the cost of the seroprevalence surveys,
and CDC one-quarter of the $2 million program).
As Novick was to write later (Novick,
1991), the newborn seroprevalence survey provided the state health
department with three critical elements: currency, relevance, and focus. The
"currency" allowed the state to monitor the real-time spread of the
infection without having to account for the lag time between HIV infection
and a reported AIDS case (and it enabled the state to conduct analyses of
HIV trends over time without adjusting for the CDC's expanded definition of
AIDS in 1993); the "relevance" of the universal screening test enabled the
state to report actual, rather than projected, infection rates among
childbearing women and to closely estimate the rate among all women ages
1544; and the "focus" derived from the small-area planning that could be
conducted given the sociodemographic variables of maternal age,
race/ethnicity, and zip code. The last was perhaps the most important to
state public health officials, since it served as an early-warning system
that alerted them to what communities the virus was moving into, and thereby
provided an opportunity for targeted prevention and education efforts.
In March 1988, Commissioner Axelrod
reconvened a special advisory committee to review the preliminary results of
the newborn serosurvey. The committee (composed of Elaine Abrams and
Margaret Heagarty of Harlem Hospital, NIAID's Richard Kaslow, the CDC's
Timothy Dondero and Margaret Oxtoby, Myron Essex and Harvey Fineberg of
Harvard School of Public Health, Keith Krasinski of Bellevue Hospital, Peter
Selwyn of Montefiore Hospita;, and Isaac Weisfuse of the New York City
Department of Health) strongly recommended continuing the serosurvey,
particularly for purposes of monitoring the epidemic.
Only days before the advisory committee
met, an article in Newsday (a major New York daily) featured an
interview with Dr. Rodney Hoff, the architect of the Massachusetts health
department's blinded newborn survey. Even as he presented the rationale for
the blinded serosurvey, ". . . so that we can monitor HIV infection trends
in women," he did sound a cautionary note, saying that, "there is a
trade-off here between the legal issue of consent and ethical issue of duty
to inform." Since there was no accepted treatment at the time, Hoff said he
considered it ethically acceptable to not identify individual patients (a
position adopted by Bayer and others (1986), and by the journal Nature's
editorialists in a 1987 article). "Once there is an effective treatment
for infected infants," he concluded, "we will very quickly convert to a
Between 1988 and 1990, the New York State
health department pursued a number of measures predicated on voluntary
adherence to primary and secondary prevention practices. In the absence of a
treatment or vaccine, public health strategies focused first on preventing
initial infection (primary prevention) by modifying risk behaviors and, for
those infected, on preventing further spread of the virus (secondary
prevention). Tertiary prevention efforts, focused on limiting the
progression of the disease within an infected individual, were for the most
part limited to PCP prophylaxis and experimental antiretroviral therapies.
As has been extensively documented, since HIV/AIDS raised so many issues of
the authority of the public health officials to intervene in the private
affairs of selected communities (e.g., gay bathhouse closures, mandatory
partner notification) and since there had been sufficient numbers of cases
of HIV/AIDS discrimination in housing, public schools, and employment to
warrant a genuine concern, public health officials generally believed that
the most expeditious prevention strategy had to be voluntarily elicited,
rather than coerced or mandated. Furthermore, such an approach followed the
principle of the "least restrictive alternative" in gauging appropriate
public health action.1
Particularly given some of the early successes in persuading the homosexual
male population to voluntarily reduce risky behaviors, it seemed sensible to
public health officials and legislators to pursue measures that educated and
engaged the communities most at risk, rather than potentially alienating
these communities and driving them away from the health care system.
In keeping with this approach, the state
legislature passed New York State's confidentiality statute in 1988, which
imposed strict penalties for disclosure of confidential HIV information and
required written informed consent prior to any HIV testing. According to one
of the key legislators involved in drafting the law, "We recognized that
there was an urgent public health need to have people come forward and be
tested, to be counseled, and to cooperate, and since there was no lure of
treatment we had to offer a guarantee of confidentiality." One key provision
of the statute gave physicians treating HIV-infected individuals the "power"
to warn others who might be at risk of HIV infection, but not the "duty" to
warn. This was in keeping with the balance between prevention and case
finding, as was the language of the informed consent. Rather than adopting a
"directed" approach that recommended HIV testing, the language of the
informed consent was "non-directed," spelling out all the potential negative
consequences of testing and leaving the formulation of a decision entirely
up to the individual. This approach to informed consent was based on 20
years of success in the field of genetic counseling and was driven by
various consumer movements promoting both patients' rights and autonomy, and
a shared medical decision making model that regarded the patient as an
active partner along with his or her health care provider.
The state health department codified its
strategy in two key planning documents: (1) the January 1989 five-year
interagency plan, "AIDS: New York's Response," which introduced a number of
new initiatives aimed at education (such as HIV/AIDS education incorporated
into the core curricula of all public schools and colleges), voluntary
counseling and testing, expansion of health services, and preservation of
human rights through antidiscrimination legislation and adherence to the
principles of informed consent; and (2) the "New York State Principles for
the Care of Women and Children with HIV Infection," (New York State AIDS
Institute, 1990) drafted after a three day symposium in 1990 at the Mohonk
Mountain House in New Paltz, and thereafter known as the "Mohonk
Principles." The Mohonk symposium, led by the AIDS Institute's Nick Rango,
brought together key staff from a number of state agencies, as well as
health professionals involved in AIDS-related services and women affected by
the epidemic. The document clearly stipulated the state's voluntarist
approach. The consensus document urged "routine counseling and voluntary
testing of all women of reproductive age," which should be provided in all
health care settings; it asserted each woman's right to make her own
reproductive choices; and it recommended a program of routine counseling and
voluntary testing of postpartum women who may not have received adequate
counseling or testing opportunities prior to giving birth. The document
further clarified a consensus position opposing mandatory newborn screening,
arguing that involuntary testing of the mother (the practical consequence of
newborn testing) must be weighed against the state's interest in
safeguarding the health and welfare of the infant. It presented the criteria
that had to be met before unblinding the newborn screening: "(1) substantial
clinical benefit of treatment in HIV-infected newborns has been
demonstrated; (2) appropriate clinical services are available to all
HIV-infected family members regardless of family resources; (3) a definitive
laboratory test becomes available allowing for the detection of HIV
infection in newborns (as opposed to the presence of maternal antibodies),
or the indicated clinical intervention for infants with HIV infection
has been proven to be sufficiently non-toxic to uninfected infants who would
receive it because of the presence of maternal HIV antibodies; and (4) a
system of voluntary counseling and testing of all women of reproductive age
has failed to be effective."
The voluntary counseling and testing
program at family planning clinics and prenatal care programs was emblematic
of this approach. The state intended that every woman of reproductive age
seen in a state-regulated facility would be provided with sufficient
information to protect herself from being infected and that every woman
would also voluntarily take the HIV test in an effort to inform reproductive
choices (such as whether to have an abortion or to pursue future
pregnancies) and to encourage other secondary prevention efforts. In 1990,
state health officials also rejected the CDC's 1989 recommendation for
risk-based assessments--which attempted to concentrate efforts on
encouraging testing among individuals in specific self-reported high-risk
categories--in favor of a broader, universal approach that sought to gain
the consent to test among all women at state-regulated clinics. In September
1990, the health department sent out a "Dear Colleague" letter to all
physicians in the state, urging them to counsel any patient who had sex with
more than one person in the last ten years, or who had ever used illicit
drugs, to be tested for HIV. Furthermore, the state launched the OB
Initiative in 1990, a postpartum program at 24 hospitals in high-seroprevalence
areas to counsel and test women who indicated they had not been tested
during their pregnancies.
The results of these voluntary programs,
though, proved disappointing. Testing rates in 1991 and 1992 ranged from 14%
to 66% (Healton et al., 1996) at the women's clinics, and except for Harlem
Hospital's program, which persuaded over 90% of postpartum women to test,
the OB Initiative was equally ineffective. Although the merits of case
finding versus prevention were debated, it was increasingly evident to
public health officials in the early 1990s that such voluntary case finding
strategies needed strengthening.
At the same time that these programs
directed at individual behavior change were being initiated, a number of
efforts were undertaken by the state health department to more accurately
focus community-wide prevention and treatment efforts. One innovation
developed by the AIDS Institute and the state's epidemiology unit was a
Community Needs Index, which took into account newborn seroprevalence rates
and hospital discharge data in constructing a profile of high-, medium-, and
low-risk neighborhoods. The index was then used in program development, the
expansion of specially designated AIDS centers at hospitals and community
health centers, and the distribution of state funds to community-based
organizations in high-risk neighborhoods.
From an epidemiological perspective,
universal newborn screening was still regarded as effective and relevant.
Beginning in 1990, though, as treatment options for HIV-infected infants
became more widely accepted, the tension between the epidemiological and the
clinical utility of newborn screening (in very broad terms, the polarization
of surveillance and prevention versus case finding and treatment) grew
within the state health department. These issues had percolated within the
larger health care community since 1988 (Krasinski et al., 1988), but now
they were gaining a wider audience. What began as an internal debate within
the health care community in the late 1980s evolved into a very public
debate by 1993.
THE SEEDS OF DISCONTENT, 19901993
By 1990, Commissioner Axelrod was having
second thoughts about the state's blinded seroprevalence study. The Fifth
International AIDS Conference in Montreal the previous summer had featured a
number of promising studies suggesting the value of specific prophylactic
therapies directed at infants, and the CDC was in the process of formulating
new guidelines for PCP prophylaxis for infants and children that would be
released in 1991. The efficacy of such treatment, as with antiretroviral
therapy in adults, was dependent upon early detection of the viral
infection. Axelrod convened his chief deputies and discussed the possibility
of replacing the blinded newborn screening program with one in which
newborns carrying the HIV antibody would be mandatorily identified and a
parent notified. Nick Rango, director of the AIDS Institute, was vehemently
opposed and urged Axelrod instead to redouble his efforts on the voluntary
testing program. As the data continued to show, though, women were not
voluntarily stepping forward to be tested. In late 1990, Axelrod asked one
of his key deputies to assemble a small team and draw up a plan for
unblinding the newborn study. The plan was to include how notification would
be made, how to bring women back for comprehensive care and treatment, and
how to assure sufficient capacity at existing designated AIDS centers to
care for the women and children. At first, the team considered an approach
that involved giving each woman the "right of refusal," but rejected that as
having too many problems. If settled instead on a plan of mandatory newborn
testing and notification, along with assured treatment for all who tested
positive. The AIDS Institute's Rango continued to object to the approach.
In February 1991, Axelrod suffered an
incapacitating stroke. Despite its advocates within the health department,
the plan to unblind the newborn testing was shelved. "We had no
commissioner," said one veteran public health official who favored the plan,
"and no one with the political resources to pull it off."
Outside the health department, indeed
outside the medical community, there was an increasing interest in
revisiting the newborn testing issue. In mid-1991, Gretchen Buchenholz,
executive director of the Association to Benefit Children (ABC), a New York
City-based foster care agency, approached her legal counsel to lead a
lobbying campaign to unblind the newborn screening study. After several
cases in which foster children had gone undiagnosed with HIV infection
despite their caregivers' interest in obtaining an HIV test for the infant,
and which was attributed to the restrictiveness of the state's
confidentiality statute in not allowing foster parents to order an HIV test
without the natural parents' consent,2
the agency decided that the most effective strategy would be mandatory HIV
screening of all newborns, with a guaranteed provision of care for all who
tested positive. The special counsel and the executive director of ABC
approached a number of agencies to enlist them in the campaign. According to
their published accounting of these lobbying efforts, they were rebuffed by
the state AIDS Institute, the Lambda Legal Defense and Education Fund, and
the Gay and Lesbian Rights Project of the American Civil Liberties Union.
But they did receive positive support from certain children's rights groups.
For three years, ABC continued to seek common cause with other HIV/AIDS
providers, and it was not until 1994 that ABC decided to use a litigation
strategy to advance its position.
Some of the strongest dissenting voices
opposed to blinded newborn screening study in 1992 came from Nassau County
on Long Island, a predominantly conservative area just east of New York
City, and in the reportage of the area's leading daily newspaper, Newsday.
In the summer of 1992, the Nassau HIV Commission recommended to the local
board of health that it petition the state to allow mothers to consent to be
notified if their infants tested positive for HIV. The commission also
lobbied the Nassau Count Board of Health to recommend to the state that all
physicians throughout the state be required to offer an HIV test to their
pregnant patients. One Nassau County Board of Health member, Dr. Larry
Ravich, said during the board meeting at which the commission's
recommendations were presented, "I think we are approaching this with little
slippers on." He pressed for mandatory HIV testing of all pregnant women, a
position adopted by the board. Several days later, Newsday columnist
Bob Wiemer endorsed the board's push for mandatory HIV testing. He referred
to the 1988 confidentiality statute that stood in the way of such mandatory
testing as "criminally foolish," and argued that under the existing laws,
"the rights of the carrier are held superior to the rights of the
uninfected." Although the Nassau County Board of Health's recommendations
did not alter state policy, they did demonstrate a breach within the public
health community. And the columnist's sentiments, however inflammatory they
appeared at first glance, would soon gain currency in the legislative
efforts to unblind newborn screening.
In January 1993, Newsday ran a
series of articles by reporter Nina Bernstein that documented the failure of
voluntary partner notification to protect unsuspecting women from
HIV-infected husbands. The articles were powerful and dramatic, and the
stories the reporter recounted of women learning their husbands' diagnoses
as they lay on their deathbeds--sometimes as a result of an inadvertent slip
by a social worker or physician caring for the husband--made a strong case
for stronger partner notification policies. The state health department and
the state legislature were implicated in the failure to protect these women,
and it so infuriated state Assemblywoman Nettie Mayersohn as she read the
newspaper series that she grew determined to change state law. Within weeks
of reading the newspaper articles, at the start of the legislative session,
Mayersohn, a Democratic majority member of the Assembly's Health Committee,
proposed amending the public health code. Her proposed legislation would
require named reporting of HIV-infected individuals to the local health
department and mandatory partner notification if the infected individual
voluntarily released the names of sexual contacts. As a politician and
community activist with a long history of supporting women's rights,
Mayersohn perceived herself to be operating from a similar position, that of
protecting women from unfair policies and inequitable relationships. She
sought support for her position from a variety of women's groups and gay
activists, and was surprised at their rebuff. Next, she went to the medical
community. After a presentation at the Medical Society of the State of New
York, a physician approached her and told her about the state's policy of
blinded newborn screening. He presented it as the greatest travesty of the
state's confidentiality statute--that the state knew the HIV status of
infected babies, but would not let either the mothers or the physicians
know. Notwithstanding the inaccuracies of such a portrayal--the state did
not maintain the identities of the HIV-infected babies, nor was it
preventing or denying the ability of mothers to test or physicians to
strongly counsel their patients to test--this captured Mayersohn's attention
completely. After verifying the facts of the blinded newborn screening
policy, she decided to shelve her partner notification legislation and
devote all her legislative energy towards the passage of the "Baby AIDS"
bill she introduced in May 1993, which would unblind newborn screening and
mandatorily notify the parents of the baby's status. "The secret is out,"
Mayersohn wrote in one of her first newsletters on the subject in 1993, "the
State of New York has been using babies for statistical purposes--but has
been denying them treatment and the protection they need to save their
lives." Her legislation was mirrored in the state senate in a bill sponsored
by Guy Velella, a Republican from the Bronx.
Given the response to her partner
notification legislation, Mayersohn was hardly surprised by the vehement
opposition she encountered from gay activists, civil libertarians, and
feminist groups. Still, she was confident that her constituency of
middle-class, mostly Jewish homeowners in Queens would support her position
as one consonant with her "pro-family" stance. She set aside virtually all
other legislative business to focus on the newborn testing issue. According
to Mayersohn, "This was an issue that people would respond to. I was
horrified. I couldn't focus on any other political agenda." Her doggedness
was not overlooked by her fellow Assembly members, especially those who
opposed her legislation. According to one legislative leader, "It is rare to
see a legislator focus her career down to one question. She was irrelevant
to the legislative process [once she began pursuing the Baby AIDS
legislation], but that fixation contributed to her success. It was clear to
me from the start that it would be extremely difficult to overcome her
Mayersohn's proposed legislation to mandate
newborn testing proved to be a turning point in the evolution of policy.
Whereas the locus of decision making control over newborn testing had
resided within the state health department from 1987 through 1992, the
debate and decision making over newborn testing now entered the public and
political realms. Public health officials had become secondary actors in the
policy making process. Whatever their personal inclinations to advocate or
oppose mandatory newborn testing, their role became that of functionaries
rather than trusted advisers. Public health officials would provide the
legislators and advisory committees with data, and would work on the
implementation of the interim and final policies regarding newborn testing,
but they would no longer steer the process.
POLITICAL MANEUVERINGS, 19931994
Mayersohn introduced her 1993 legislation
in the political environment of a Democratic Assembly (100 of 150 seats); a
Republican Senate; and a three-term liberal governor, Mario Cuomo, as the
state executive. Both state houses operate under protocols of centralized
leadership: the Assembly speaker and the Senate majority leader each have
the power to move legislation out of committee for a floor vote or to block
votes from coming up the floor. Until procedural reforms were enacted in the
1998 legislative session, the legislative leaders also controlled budgetary
decisions; the state budget was determined by negotiation among the Assembly
speaker, the Senate majority leader, and the governor. In 1993, Mayersohn
had little influence either with Speaker Sheldon Silver, a Manhattan
Democrat, or with Governor Cuomo.
A former community activist who first ran
for political office when she was in her mid-fifties, Mayersohn's greatest
political assets were her persistence and the image she presented of herself
as a plain-speaking Jewish grandmother. In her home district in Queens,
Mayersohn had been a tenant organizer, president of the PTA, and a
Democratic district leader. She had returned to college after raising a
family and graduated from Queens College alongside her youngest son.
Although she had run against a Democratic incumbent to gain her Assembly
seat, Mayersohn fostered some key political ties amongst fellow Queens
Democrats. When she was a district leader, Mayersohn helped Gary Ackerman
campaign successfully for a state Senate seat, and the two kept in contact
after he became a U.S. Congressman. In 1995, Ackerman would play a pivotal
role in the shifting national debate about newborn testing when he
introduced a bill modeled on Mayersohn's New York bill.
The populist image Mayersohn cultivated was
that of an independent thinker, not beholden to the party line, who was
devoted to protecting those without power (such as women and babies). Also,
based on the relative homogeneity of her home district and her strong record
of constituent service, Mayersohn enjoyed very strong electoral support. In
order to bolster her position and gain the endorsement of her fellow
legislators, Mayersohn would photocopy relevant medical journal articles and
newspaper reports that supported her arguments and circulate them to all of
Mayersohn was well aware that her bill
faced an uphill battle, particularly given what she called the "Manhattan
constituency," by which she meant legislators whose most vocal leftist
constituents constrained the legislators from voting their consciences and
who instead favored special protections and undue entitlements. Chief among
her opponents was Richard Gottfried, a Manhattan Democrat who chaired the
Assembly's Health Committee. As one of the original drafters of the 1988
confidentiality statute, he was a staunch supporter of voluntary programs.
After several newspaper editorials came out in favor of Mayersohn's proposed
legislation (including the New York Times and Newsday), and
there was mounting legislative support for her bill, Gottfried moved to
table her bill pending a report by a panel of clinicians and ethicists
constituted as a subcommittee of the AIDS Advisory Council and known as the
"Blue Ribbon panel." The motion to table the bill barely passed by a 109
vote in August 1993. The Blue Ribbon panel was expected to deliver its
report in early 1994.
"At the beginning," said one legislative
leader who favored voluntary testing, "we were trying to buy time, to build
an opposition. When [Mayersohn] raised the issue in Spring 1993, Jim Tallon
[the Assembly majority leader] came up with the idea to reach out to [Dr.
David] Rogers [the chair of the AIDS Advisory Council] to create a
subcommittee to study the issue. It had support from the Speaker. If the
Blue Ribbon panel had not been there the bill might have passed into law
Between September and December 1993 the
Blue Ribbon panel held five public meetings and a public hearing in a packed
Manhattan conference room. In late January 1994, the chair of the Assembly's
Health Committee, Richard Gottfried, wrote an op-ed piece reaffirming the
importance of voluntary testing programs. "Treating a patient with
consideration and respect--which includes relying on informed consent--is
the best way to win that patient's cooperation." He reiterated his position
that counseling every pregnant woman would find and treat more HIV-positive
babies than a mandatory approach because it would involve the women in their
care, and he concluded with a call for mandatory counseling of all women.
On February 10, 1994, the Blue Ribbon panel
issued its recommendations. During its deliberations, the panel had
considered the range of mandatory and voluntary testing options, the
potential timing of such HIV testing (prenatally or antenatally), and the
available treatment opportunities for women and infants identified as
HIV-positive. Furthermore, the panel had considered the effects of various
treatment options on two outcomes: (1) increasing the percentage of
HIV-positive women and infants who were tested and (2) increasing the rate
at which infected and exposed women and infants could be expected to enter
treatment. Given that HIV testing during the prenatal period provided
greater opportunities for counseling and informing mothers, avoided the
possibility of losing as many cases to follow-up if HIV test results were
delayed postpartum, and offered the greater opportunity for preventing
perinatal transmission if the ZDV clinical trial proved successful, a
majority of the panel rejected the mandatory newborn testing policy and
instead recommended mandatory HIV counseling for all pregnant and postpartum
women. The panel further urged the development of intensive counseling
programs similar to that of Harlem Hospital, which routinely persuaded over
90% of its obstetrical patients to accept HIV testing. Four physicians on
the panel--the public health commissioner from Westchester County and three
pediatricians--dissented. One of them, Dr. Lou Cooper, the head of the New
York chapter of the American Academy of Pediatrics, told the New York
Times, "Reliance on counseling that encourages voluntary testing ignores
the unacceptably high failure rate of such an approach. In addition, it
siphons off resources which could be focused more effectively for needed
Within days after the Blue Ribbon panel
released its report, the Data Safety Monitoring Board of the NIAID
interrupted AIDS Clinical Trials Group protocol number 076 (ACTG 076) when
it became clear that ZDV administered to pregnant women and newborns could
reduce vertical transmission of HIV by 69%. Citing the dramatic,
incontrovertible value to intervening prenatally, Cooper reversed his
position and sided with the majority view of the panel to focus prevention
and case finding efforts on pregnant women rather than newborns.
On February 24, 1994, the AIDS Advisory
Council adopted the Blue Ribbon panel's recommendation and advised the state
to pursue universal voluntary testing. On the same day, a joint
SenateAssembly bill was proposed by Michael Tully, the chair of the Senate
Health Committee and Assembly Speaker Sheldon Silver, calling for mandatory
counseling and voluntary testing of pregnant women. The sponsors pointed to
the recent reports of ZDV's efficacy as a clear mandate to focus efforts on
enlisting pregnant women in the detection and care of their HIV-infected
babies. The battle over Mayersohn's bill had clearly been joined.
columnist Jim Dwyer, who would later win a Pulitzer Prize for his series of
columns on the Baby AIDS legislation, published a column in April, 1994, "A
Silence that Kills Children," prompted by a conversation he had with
Mayersohn that transpired after he had attended the funeral of a baby who
died from AIDS complications (Mayersohn, 1994a). In the column, he quoted
pediatrician Stephen Nicholas of Columbia Presbyterian Medical Center as
favoring "routine newborn testing, the same we do for syphilis testing."
Nicholas, who had been involved in the design and implementation of Harlem
Hospital's much-touted High Risk Pregnancy Clinic, told the columnist that
he felt that even 90% voluntary agreement to test was not sufficient,
"because you're still missing 10%."
Throughout the early spring, there was
considerable political discussion and negotiation over possible terms of
compromise between the SilverTully sponsors and the MayersohnVelella
sponsors. One compromise being considered was directed counseling that urged
HIV testing and the written acceptance or refusal of testing at delivery. At
the same time, the foster-care agency ABC had renewed its advocacy for
allowing HIV testing of foster children without explicit consent of the
birth parents, a policy that many saw as linked with the mandatory newborn
testing proposals because both would amend the state's confidentiality
statute and both would be undertaken on behalf of HIV-infected children. ABC
and its pro bono counsel had made it clear to the state commissioners of
social services and health that they would pursue a lawsuit against Governor
Cuomo and the state. On June 6, 1994, only days before the lawsuit was to be
filed, the commissioner of social services announced new regulations that
would allow foster children to be tested after a good-faith effort to locate
had been made the natural parents. The regulations would be adopted on an
emergency basis, which meant that within a year the agency would have to
hold hearings and adopt the regulations permanently. ABC, satisfied with the
compromise, dropped its plans for a lawsuit.
Throughout June, the battle over the Baby
AIDS bill intensified, particularly since the end of the legislative session
was scheduled for the first week of July and there was a major election
looming in November. Newsday columnist Dwyer wrote one column
referring to the "corrosive influence of a Religious Left" backed by
well-paid Albany lobbyists, which was marked by dogma that held that any
threat to a woman's right to privacy was a threat to abortion, that any
abrogation of the state's confidentiality statute was the first step on a
slippery slope to the persecution of people with AIDS, and that mandatory
testing would drive mothers away from medical care.
New York Times
columnist Anna Quindlen (1994) took the opposing view: "The word on the
mandatory reporting measure is that it is opposed only by special interest
groups, gay organizations obsessed with privacy, and feminists concerned
only with women. Why then is it opposed by Lorraine Hale, whose Hale House
has been caring for sick and abandoned babies for years?" Quindlen concluded
that "the Baby Bill sounds so right; the mothers, with all their many
problems, are not so sympathetic. But winning their trust and cooperation,
not coercing and blindsiding them, is how real change will occur."
The results of ACTG 076 had changed the
terms of the debate for a number of individuals and organizations. Both the
New York chapter of the American Academy of Pediatrics and the Medical
Society of the State of New York reversed their positions on mandatory
testing, favoring instead a policy of mandatory counseling for pregnant
women and voluntary testing. Given the existence of an effective treatment,
a number of clinicians were loathe to institute a policy that might drive
any women from care, and a number had seen the clinical opportunity shift
from the delivery setting--which many regarded as too late for effective
intervention--to the prenatal setting.
The Republican candidate for governor,
State Senator George Pataki, announced in early June that he favored
mandatory HIV testing of newborns, a position that was echoed by the
candidate for state attorney general, Dennis Vacco, running on Pataki's
ticket. Governor Cuomo had still not taken a public stand. In early spring,
months after the AIDS Advisory Council had released its recommendations,
Governor Cuomo charged the Task Force on Life and the Law with reviewing the
issue of mandatory HIV newborn testing. According to one member of that
advisory panel, which often addressed ethical issues of concern to the
governor, Cuomo wanted to delay his decision until after the gubernatorial
Right up to the end of the legislative
session in early July, supporters of the SilverTully bill calling for
mandatory counseling and voluntary testing believed their bill would pass in
the final hours. Even Mayersohn had accepted the likelihood of her
opponents' bill passing. "I left at midnight [on the last night of the
legislative session] thinking this would pass. [Newsday columnist]
Dwyer called me the next morning to say the bill wasn't introduced. It was
never put up for a vote. That left an opening for our bill to be
reintroduced in the 1995 session." Mayersohn harbored no illusions as to the
impact of the upcoming gubernatorial elections. "With Pataki, I had no doubt
that if he won we would see a different force at work. The activists would
not have the same influence they had under Cuomo."
In November 1994, George Pataki narrowly
defeated Mario Cuomo for governor.
POLITICAL MANEUVERINGS, 19951996
Shortly after Pataki assumed office, he
held to one of his campaign promises to limit government by placing a
moratorium on the promulgation of any new regulations. Ironically, this
included the Department of Social Services's effort to create permanent
rules for the HIV testing of foster children after its emergency rule making
of 1994. The Association to Benefit Children felt that its negotiated
victory was in jeopardy and began preparing another lawsuit. In mid-March,
ABC sued the governor on behalf of "Baby Girl" seeking routine HIV testing
for all newborns, and treatment and counseling for all HIV-positive infants,
mothers, and other family members. Mayersohn had encouraged the lawsuit,
since she felt it would help advance the cause of mandatory testing. The HIV
Law Project, a legal advocacy group representing HIV-infected women,
petitioned the court to be added as a "defendantintervenor" since it felt
that the state would not adequately represent its own interest in
maintaining the voluntary testing program, given the campaign statements of
both Pataki and Attorney General Dennis Vacco.
There was little doubt as to the new
administration's agenda concerning newborn testing. When Pataki's nominee
for health commissioner, Dr. Barbara DeBuono, commented in an appointment
hearing that she supported voluntary testing over mandatory testing
approaches, Mayersohn placed a call to the governor. Within a couple of
days, DeBuono had reversed her position and proffered her support for
pursuing mandatory newborn testing.
Actions at the federal level in the spring
of 1995 were felt at the state level as well. In March, Congressmen Ackerman
and Coburn introduced H.R.-1289, an amendment to the Ryan White
Comprehensive AIDS Resources Emergency (CARE) Act which would require states
to disclose the HIV status of newborns. The amendment gained broad
bipartisan support, including from the congressional Black Caucus and such
progressive representatives as Ronald Dellums and Patricia Schroeder. In
response, in May 1995 the CDC suspended its anonymous HIV Survey of
Childbearing Women. According to one senior New York public health official,
the state health department decided to continue its program of newborn
surveillance without the $500,000 provided by the CDC. "After Mayersohn
began agitating," the official noted, sharply contrasting the state response
to that of the federal public health agency, "it would not have been
politically astute to pull it."
After Mayersohn and Velella reintroduced
their mandatory testing bills, there was again a great deal of movement to
strike a compromise before the end of the legislative session in early July.
Late in the evening on one of the last nights of the session, a member of
Assembly Speaker Silver's staff approached Mayersohn. The speaker was
willing to amend the law to allow the health commissioner to order the HIV
test, rather than mandate it by law. Mayersohn readily accepted the
compromise. This time, as the legislative session drew to a close, Mayersohn
was convinced that her position would prevail. As happened the previous
year, though, the legislation that everyone expected to pass was not brought
to the floor. According to various accounts, the speaker had been approached
by Assembly Democrats opposed to mandatory testing, so he had decided
instead to await the resolution of the AckermanCoburn amendment in the
House of Representatives.
In September 1995, the state attorney
general approached ABC to settle its lawsuit. Since the governor could not
change the confidentiality statute by executive order, the state was limited
to working within the bounds of an arrangement that included written
informed consent. The two sides (absent the HIV Law Project) settled upon a
compromise. The state would propose rules by which postpartum women would be
approached for consent to have their infant's HIV status disclosed, and
there would be a provision allowing a physician to conduct HIV testing if he
or she determined that an emergency existed. According to ABC counsel Colin
Crawford, in retrospect ABC "could have considered the possibility of
voluntary testing following a compelled choice either to learn the results
or not, far earlier than we did. We could have come to this realization,
moreover, from working even harder than we did to try and accommodate the
confidentiality and civil liberties of our opponents."
Richard Gottfried, chair of the Assembly
Health Committee, was not unhappy with the settlement. "For some people, the
ABC lawsuit gave legitimacy to Nettie's position. But, in fact, it was
almost exactly what I would have wanted to have as state law." The only
critical difference, according to Gottfried, was that the proposed rules
would mandate directed HIV counseling only in state-regulated facilities
(such as hospitals, clinics, and certain HMO practices), whereas the
SilverTully bill he had cosponsored would require all physicians--whether
regulated or not, public or private--to provide mandatory counseling.
In settling the lawsuit, Governor Pataki
was quoted in the New York Times as saying, "This is as far as we can
go in the absence of legislative action." Mayersohn announced she would
reintroduce her bill in January 1996. Pataki, supporting Mayersohn, said he
would sign the bill if it crossed his desk.
Over a period of five months, the state
health department worked with the governor's office to develop rules and an
implementation plan for what was being called the "Consented Newborn HIV
Testing Program." As implemented on May 1, 1996, the regulations required
that women in labor must sign a written consent form, and if neither consent
nor refusal is present a physician may order the HIV test. If the woman
provided written consent, she would receive the results of her newborn's HIV
test, would consent to follow-up testing of the baby after discharge to
determine if the baby was truly infected, and would authorize the disclosure
of the baby's test result to appropriate programs and the state health
department to ensure that the baby received follow-up and specialty medical
care. The facility providing maternity services would be responsible for
identifying a physician to receive the HIV test results, preferably the
baby's pediatrician. Post-test counseling would be provided at the time the
woman was notified of the test results, and the pediatrician was required to
order a polymerase chain reaction (PCR) test on newborn to determine if the
infant was HIV infected or was only manifesting the mother's antibodies. If
the state newborn screening program did not receive the PCR specimen within
five to six weeks after birth, it would contact the hospital designee or
pediatrician for further follow-up.
Women could refuse notification of results,
in which case the screening would remain anonymous and be used for
epidemiologic purposes only. If a woman in the newborn setting did not
provide written consent or refusal, her physician could act in the absence
of parental consent "when a medical emergency exists for the infant."
According to state health department officials, over the nine-month period
of the Consented Newborn HIV Testing Program, this emergency provision was
exercised only four times--in two cases the babies had been separated from
their mothers, and in one case the mother was comatose.
Notwithstanding the compromise reached over
the lawsuit, in the months surrounding the implementation of the Consented
Testing Program the mandatory testing legislation reintroduced by Mayersohn
and Velella gained considerable momentum. In late April, House and Senate
negotiators came to an agreement over mandatory testing as part of the Ryan
White CARE Act reauthorization. House Republicans agreed to support the
position of the Senate conference committee, the American Medical
Association, and the National Governor's Association calling for a five-year
trial period of voluntary testing before instituting mandatory newborn
testing. As signed in June, the Ryan White CARE Reauthorization Act required
states to demonstrate that they had satisfied one of the following criteria,
or face the loss of their Title II funding: either (1) a 50% reduction in
AIDS cases from perinatal transmission compared with 1993 data; (2) HIV
testing of at least 95% of pregnant women who had received at least two
prenatal visits prior to 34 weeks gestation; or (3) a program of mandatory
testing of all newborns whose mothers had not under gone prenatal HIV
Also in June 1996, Assembly Speaker Sheldon
Silver reversed his position on mandatory testing legislation and allowed
the bill to pass the legislature. According to one legislative insider, "The
Assembly leadership did not want to go into 1996 elections with this as an
open issue. In 1994, the U.S. House and Senate went Republican, as did the
New York governor. In 1996, the Speaker was very concerned this [opposition
to mandatory testing] would lead to a loss of a significant number of
Assembly seats, and that would then invigorate the Republicans. We could
potentially lose majority control. That got played out on a long list of
issues, whether criminal justice, or welfare reform, or mandatory testing."
On June 26, 1996, Pataki signed the Baby AIDS bill into law. The new law
gave the health commissioner the authority to impose newborn HIV tests.
According to Speaker Silver, "We're leaving it to the health professionals
to make the determination."
As expected, Health Commissioner Barbara
DeBuono issued a call for developing regulations to put the mandatory
newborn HIV screening program into place, and on February 1, 1997, the
Comprehensive Newborn Testing Program was implemented.
In the wake of the mandatory newborn
testing policy which began in 1997, Mayersohn returned to her original
proposed partner notification legislation from 1993. According to one
observer, "The success of the Baby AIDS program [mandatory newborn testing]
was a major arguing point in the efforts to pass partner notification, and
the lines of support were parallel." A number of county health officials,
the state medical society, and a number of physicians supported the effort;
similarly, a number of community groups, civil libertarians, and physicians
opposed to mandatory newborn testing also opposed the partner notification
legislation. The case of Nushawn Williams, an HIV-positive Brooklyn man who
infected a number of underage teenage girls through sexual contacts in rural
Chatauqua County in 1997, further fueled public debate and interest in the
partner notification legislation. According to public reports about the
case, although Williams was aware of his HIV-positive status he did not
disclose it to the girls with whom he had intercourse. A number have since
tested positive for HIV.
Mayersohn's reintroduced bill requires
providers to solicit the names of sexual contacts and injection drug-using
contacts from individuals who test positive for HIV. Physicians,
laboratories, coroners, and medical examiners are required to report the
names of individuals testing positive and their contacts (if known) to the
state health commissioner. In turn, the state will then forward the
information to the local health commissioner or district health officer.
Local health officers are required to trace the sexual and/or drug-sharing
contacts of HIV-positive individuals, inform them of their risk, provide
counseling, and direct them to testing and treatment centers. Rigorous
confidentiality standards are required, and the identity of the index case
may not be revealed to the partners who are traced. Furthermore, a special
protocol would be developed for individuals at risk of domestic violence. In
addition to the "duty to warn," the legislation also allows the commissioner
to establish a named HIV registry similar to that in effect in 27 other
states. Mayersohn's bill was tabled for further discussion in 1997 and
passed both houses of the legislature in the closing days of the 1998
session. The bill was signed into law by Governor Pataki on the last day of
the legislative session in June 1998. After regulations are drafted and
comments received, the law will go into effect on January 1, 1999.
The combined partner notificationnamed HIV
registry legislation signified a further breach of New York's exceptionalist
HIV policy. With some notable exceptions--such as the development of Special
Needs Plans for HIV-positive Medicaid recipients, rather than pooling them
with the rest of the Medicaid managed care population--public health policy
regarding HIV-positive individuals has tended toward the more traditional
approaches of case finding, containment, and chronic disease management.
Under the Pataki administration, the
composition of the AIDS Advisory Council has changed as well, since the
governor can appoint 9 of the 17 council members. There is less
representation from advocacy groups and community interests, and a greater
voice of traditionalist public health as represented by several suburban
health commissioners. The governor also appointed Mayersohn's legislative
counsel, William Viskovitch, to serve on the council.
Mayersohn herself has continued to support
her agenda on a national scale, through a growing electronic network that
includes contacts in Delaware, a medical society in California,
congressional staff, an Indiana-based children's publisher, and a number of
physicians who treat HIV-positive patients.
The state health department's AIDS
Institute is no longer entrenched in the HIV policy arena, as it was under
Axelrod and, particularly, Rango's direction. As one observer pointed out
about the AIDS Institute, "There is no policy agenda now." All policy
matters department-wide have been consolidated under a single office
reporting directly to the commissioner, such that there is no AIDS policy
distinct from that of the entire department.
Although the legislative battle over
mandatory newborn testing in New York State is over, the legal battle
continues. The HIV Law Project, a legal advocacy service for low-income
HIV-positive individuals in the Bronx and Manhattan, has pursued a dual
strategy: (1) malpractice suits against providers and institutions whose
failure to carry out timely and appropriate testing and notification
represent an abrogation of the standard of care; and (2) a lawsuit against
the state health department for failure to carry out the law fairly,
equitably, and with adequate protections. Despite the fact that the former
strategy targets individual providers, the objectiveas in the latteris to
implicate the law. Since a ruling on the HIV Law Project's request for a
preliminary injunction against the state has not yet been issued, as of July
1998 New York remained the only state to mandatorily test newborns for HIV
and notify the mother of the results. According to data released by the
state health department, in the first 11 months of the newborn testing
program (February through December 1997), 957 HIV-positive infants were
identified out of 236,663 tested. These 957 infants were born to 923
HIV-positive mothers, of whom 96 (10.4%) had not known their HIV status
prior to delivery.3
Seventy-seven cases were referred back to the state health department for
follow-up when the hospitals or physicians were unable to locate the mothers
or persuade them to return for follow-up care. Using AIDS Institute staff in
New York City and communicable disease specialists in upstate New York, the
state was able to directly locate and notify 68 of the 77 mothers; 5 mothers
had moved out of state, and 4 were lost to follow-up.
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